MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.7MM & SMALL SCREWS; GAUGE,DEPTH

Model Number 319.04

Device Problems Incorrect Measurement (1383); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation summary.Service & repair evaluation: it was reported that during an unknown procedure on (b)(6) 2020, the tip of the depth gauge for 2.7mm & small screws was bent.The repair technician reported the device tip is bent and the etch of the outer sleeve doesn't match the inner shaft.Bent is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Investigation flow: damage.Visual inspection: the depth gauge for 2.7 mm and small screws (p/n: 319.04, lot #: 8541829) was returned and received at us cq.Upon visual inspection, the slider assembly component was received with a part number: 310.01 etched on it and the tip was observed to be bent.The differences in the lot numbers between the components indicates the customer had potentially disassembled the devices for cleaning and sterilization and mixed up the components with other device components when reassembling them.Device failure/defect identified? yes.Dimensional inspection: a dimensional inspection was performed on the returned device.The outer diameter of the needle component was measured to be 1.79 mm (ca818).This is within the specification.Document/specification review : based on the date of manufacture, the current and manufactured revision of drawings were reviewed, depth gauge for 2.7mm to 4.0 mm screws: 319_04, rev.L/k.Since the exact manufactured date of the sider assembly 319.01 was not identified, the current revision of drawings was reviewed.Slider assembly: 319_01_4, rev.J.Measuring hook: 319_01_6, rev.H.Complaint confirmed? yes, the device received was broken.Hence confirming the allegation.Investigation conclusion : the complaint condition was confirmed for the depth gauge for 2.7 mm and small screws (p/n: 319.04, lot #: 8541829).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to the device incorrectly reassembled during the sterilization process.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: part number: 319.04, lot number: 8541829.Manufacturing site: haegendorf.Release to warehouse date: 12.Aug.2013.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during an unknown procedure on (b)(6) 2020, the tip of the depth gauge for 2.7mm & small screws was bent.The surgery was performed but had to be redone because they put in the wrong screws due to the depth gauge reading the wrong information.The procedure was successfully completed with the use of another depth gauge.There was an unknown number of minutes of surgical delay reported.There was no patient consequence.Concomitant device reported: unknown screws (part # unknown, lot # unknown, quantity 2) this report is for one (1) depth gauge for 2.7mm & small screws.This is report 1 of 1 for (b)(4).

• Brand Name: DEPTH GAUGE FOR 2.7MM & SMALL SCREWS
• Type of Device: GAUGE,DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10551372
• MDR Text Key: 207583271
• Report Number: 2939274-2020-04199
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189974
• UDI-Public: (01)10886982189974
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 319.04
• Device Catalogue Number: 319.04
• Device Lot Number: 8541829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1